Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome (PRADOTIM)

Toulouse University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prader-Willi Syndrome

Treatments: Drug: Oxytocin; Drug: Placebo; Drug: Placebo continuous; Drug: Oxytocin (OXT) continuous

Study type: Interventional

Funder types: Other

Identifiers

NCT02804373

13 6872 03

Details and patient eligibility

About

The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

Enrollment: 50 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prader-Willi syndrome genetically confirmed
• Absence of extension of the QT interval in the electrocardiogram
• Absence of hypokalemia

Exclusion criteria

• Psychiatric troubles
• Anomalies of the heart rhythm in significant ECG
• Hepatic insufficiency
• Renal insufficiency
• Patients presenting a pregnancy or breast-feeding
• High sensibility to OT
• High sensibility to the excipients of the product
• Patients having family history of genetic pathology causing an extension of the interval QT
• Patients having risk factors of advanced twist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups, including a placebo group

placebo daily

Placebo Comparator group

Description:

daily administration of placebo during 28 days : placebo continuous

Treatment:

Drug: Placebo continuous

24 IU of oxytocin daily

Active Comparator group

Description:

24 IU of daily oxytocin administration during 28 days : oxytocin continuous

Treatment:

Drug: Oxytocin (OXT) continuous

24 IU of oxytocin every 3 days

Active Comparator group

Description:

24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days

Treatment:

Drug: Placebo

Drug: Oxytocin